The Medical Devices Introductory Course 2020

The Process

• Design and classify your product • Select your conformity assessment option and develop your QMS, if applicable • Prepare your GSPR checklist, Technical Documentation, Risk Analysis and Clinical Evaluation Report • Make an application to your chosen NB, complete audit and review processes and receive EU certificate(s)

• Create a Declaration of Conformity and affix the CE mark • For class I register with Competent Authority (Article 31) • Place your product on the market • Do post-market surveillance and vigilance

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

43

Hints

• Familiarise yourself with the MDR requirements • For existing products: – Update your ER Checklists to comply with the GSPRs

– Update your technical documentation to comply with Annexes II and III – Prioritise workload based on certificate expiry date and expected review date (certificates issued under the MDD from 25 May 2017 can remain valid until 27 May 2024 – Article 120.2). • Consider important changes: class IIb implants, reusable surgical implants and scrutiny of high risk devices • Develop an implementation plan with your NB • If you have a UK NB or a UK Authorised Representative consider the impact of Brexit

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

44